Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Multicomponent Pain Self-Management Programme in Adults With Haemophilic Arthropathy: Protocol for a Randomised Controlled Trial
Background: Haemophilic arthropathy is associated with chronic pain, functional limitation and impaired quality of life. Pain interference may also be influenced by cognitive, emotional and behavioural factors. Evidence for structured multicomponent pain self-management programmes specifically tailored to adults with haemophilic arthropathy remains limited.
Objective: To evaluate the effectiveness of a structured multicomponent pain self-management programme, compared with usual care, in reducing pain interference in adults with haemophilia A or B, haemophilic arthropathy and chronic pain.
Methods: Approximately 70 adults will be individually randomised in a 1:1 ratio to a multicomponent pain self-management programme or usual care. The intervention will comprise three 60-minute face-to-face group sessions delivered over approximately 6-8 weeks. The programme will integrate pain education, emotional-regulation training and cognitive-behavioural self-management strategies. Assessments will be performed at baseline, immediately after the intervention and at 6 months. The primary outcome will be the between-group difference in change in Brief Pain Inventory-Interference score from baseline to 6 months.
調査の概要
詳細な説明
This is a superiority, individually randomised, partially nested controlled trial with two parallel groups and a 1:1 allocation ratio. Participants allocated to the experimental arm will receive a structured multicomponent pain self-management programme delivered in three educational cohorts of approximately 11-12 participants. The control group will continue with usual care during the 6-month study period.
The intervention will comprise three face-to-face sessions of approximately 60 minutes delivered at 3-4-week intervals. It will integrate education on pain neurobiology and modulation, emotional-regulation training and cognitive-behavioural coping strategies. Content will be specifically adapted to haemophilic arthropathy, including education on distinguishing persistent pain from symptoms suggestive of acute haemarthrosis and a standardised safety pathway for suspected bleeding.
Participants in the control group will continue routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy. Following completion of the 6-month assessment, control participants will be offered the same multicomponent programme.
Outcomes will be assessed at baseline, immediately after the third intervention session and at 6 months. The primary outcome will be pain interference assessed using the Brief Pain Inventory-Short Form. Secondary outcomes will include pain intensity, kinesiophobia, pain catastrophising, anxiety, depressive symptoms, illness perception, health-related quality of life and physical activity.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Rubén Cuesta-Barriuso, PhD
- 電話番号:0034 985103386
- メール:cuestaruben@uniovi.es
研究場所
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Madrid、スペイン
- Spanish Federation of Haemophilia
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コンタクト:
- Rubén Cuesta-Barriuso, PhD
- 電話番号:0034 985 103 386
- メール:cuestaruben@uniovi.es
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of haemophilia A or B.
- Haemophilic arthropathy previously diagnosed and documented by the participant's haemophilia treatment centre.
- Persistent or recurrent pain for at least 3 months in one or more affected joints.
- Sufficient capacity to understand the programme content, follow study instructions and complete the assessment instruments.
- Ability to provide written informed consent.
- Sufficient understanding of Spanish to complete the study procedures and questionnaires.
Exclusion Criteria:
- Neurological or cognitive impairment that interferes with understanding of the intervention or completion of assessments.
- Musculoskeletal surgery within the 2 months preceding inclusion.
- Acute bleeding episode or acute musculoskeletal event within the 4 weeks preceding baseline assessment that would preclude valid completion of the assessment.
- Concurrent participation in another structured educational or psychological intervention programme specifically targeting pain.
- Insufficient understanding of Spanish to complete the study questionnaires.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Experimental group
Participants will receive three face-to-face group sessions of approximately 60 minutes delivered at 3-4-week intervals over approximately 6-8 weeks. The programme integrates pain education, emotional-regulation training and cognitive-behavioural self-management strategies specifically adapted to adults with haemophilic arthropathy. |
The intervention comprises three structured face-to-face group sessions. Content includes pain neurobiology and modulation; distinctions between nociception, pain and tissue damage; biopsychosocial and fear-avoidance models; emotional regulation; diaphragmatic breathing; mindfulness; acceptance and resilience; physical activity; identification of maladaptive beliefs and cognitive distortions; cognitive restructuring; self-instruction; guided imagery; physiological de-arousal; and development of an individual self-management plan. Participants will also receive digital educational materials and between-session home assignments. A standardised safety pathway for suspected acute haemarthrosis will be included. |
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介入なし:No Intervention
Participants will continue their usual care, including routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy routines. They will not receive the structured pain self-management programme or its educational materials before completion of the 6-month follow-up. After the final 6-month assessment, they will be offered the same multicomponent programme as the experimental group. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain interference from baseline to 6 months
時間枠:Baseline and 6 months
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Pain interference will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-Interference score is calculated as the mean of seven items scored from 0 to 10, with higher scores indicating greater interference of pain with daily life. The primary outcome is the between-group difference in mean change from baseline to the 6-month follow-up. |
Baseline and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in pain interference immediately after the intervention
時間枠:Baseline and immediately after Session 3
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BPI-Interference score, calculated as the mean of seven items scored from 0 to 10; higher scores indicate greater pain interference. |
Baseline and immediately after Session 3
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Change in pain intensity
時間枠:Baseline, immediately after Session 3, and 6 months
|
Pain intensity will be assessed using the BPI-Severity subscale of the Brief Pain Inventory-Short Form, calculated from its four pain-intensity items. Higher scores indicate greater pain intensity. |
Baseline, immediately after Session 3, and 6 months
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Change in kinesiophobia
時間枠:Baseline, immediately after Session 3, and 6 months
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Kinesiophobia will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia-11SV. Higher scores indicate greater fear of movement. |
Baseline, immediately after Session 3, and 6 months
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Change in pain catastrophising
時間枠:Baseline, immediately after Session 3, and 6 months
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Pain catastrophising will be assessed using the Spanish version of the Pain Catastrophizing Scale. Higher scores indicate greater pain catastrophising. |
Baseline, immediately after Session 3, and 6 months
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Change in health-related quality of life
時間枠:Baseline, immediately after Session 3, and 6 months
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Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The eight SF-36 domains and the physical and mental component summary scores will be analysed. Higher scores indicate better health-related quality of life. |
Baseline, immediately after Session 3, and 6 months
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Change in depressive symptoms
時間枠:Baseline, immediately after Session 3, and 6 months
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Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Higher scores indicate greater depressive symptom severity. |
Baseline, immediately after Session 3, and 6 months
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Change in anxiety
時間枠:Baseline, immediately after Session 3, and 6 months
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Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), comprising 20-item state-anxiety and 20-item trait-anxiety subscales. Higher scores indicate greater anxiety. |
Baseline, immediately after Session 3, and 6 months
|
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Change in illness perception
時間枠:Baseline, immediately after Session 3, and 6 months
|
Illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ), which assesses cognitive and emotional representations of illness and perceived illness threat. |
Baseline, immediately after Session 3, and 6 months
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Change in physical activity
時間枠:Baseline, immediately after Session 3, and 6 months
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Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), with a 7-day recall period. Vigorous and moderate physical activity, walking and sedentary behaviour will be recorded according to the instrument scoring protocol. |
Baseline, immediately after Session 3, and 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bleeding episodes and adverse events
時間枠:From baseline to the 6-month follow-up
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Bleeding episodes, clinically relevant increases in pain and adverse events reported by participants will be recorded throughout follow-up. |
From baseline to the 6-month follow-up
|
協力者と研究者
捜査官
- スタディチェア:Ruben C Cuesta-Barriuso, PhD、Universidad de Oviedo
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HemoPain-2027
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